Bioavailability of Vitamin D2 and Vitamin D3 in Supplements Compared to Vitamin D3 and Vitamin D2 in Fortified Orange Juice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule
研究概览
简要总结
The purpose of this study was to determine whether vitamin D2 and vitamin D3 in orange juice are effective at raising vitamin D levels in the blood and if vitamin D2 and vitamin D3 in orange juice raised blood levels of 25(OH)D as well as vitamin D3 and vitamin D2 supplements.
详细描述
This study should provide valuable information about the bioavailability of both vitamin D2 and vitamin D3 formulated in orange juice compared to vitamin D2 and vitamin D3 formulated in a pill and taken with water. It is anticipated based on our previous observation that the vitamin D2 and vitamin D3 in orange juice will be at least 50% more effective in raising the blood levels of 25(OH)D than when taken in pill form.
This study will evaluate the bioavailability and metabolism of vitamin D2 and vitamin D3 in combination in tablet form. The results should provide important information as to whether a physiologic dose of vitamin D2 has a negative effect on circulating levels of 25-hydroxyvitamin D2 [25(OH)D2 ] and on 25-hydroxyvitamin D3 [25(OH)D3]. Results from this study have important implications for expanding the adequate intake (AI) recommendations for vitamin D2 and vitamin D3 for adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults of all races ages 18 years and older
排除标准
- •Pregnant and lactating women
- •History of chronic severe liver (as defined by liver function test greater than 2 times upper limit of normal)or kidney disease as defined by a serum creatinine >2.
- •History of taking a daily supplement that contains 400 or more IU vitamin D2 or vitamin D3 within the past month or taking a pharmacologic amount of vitamin D2 or one of the active vitamin D analogs including Zemplar (Paricalcitol), Dovonex (calcipotriol), Hectorol (vitamin D pro hormone)
- •Subjects who are taking orally Dilantin or glucocorticoids.
- •Exposure to a tanning bed or tanning on a beach for more than eight hours within the past month.
- •Subjects who drink more than 2 glasses (16 oz) cups of milk a day.
- •Known history of elevated calcium. (> 10.5 mg% (mg/dl))
- •History of intestinal malabsorption (i.e. Cystic Fibrosis, Fat malabsorption Syndrome, Crohn's Disease)
- •Allergies to orange juice
- •Any medical conditions in which it is not advisable to receive one 8 oz. glass of orange juice per day.
- •Currently taking, or having taken less than one month prior to start of study, a prescription vitamin D
- •Unwilling to consent to this trial
研究组 & 干预措施
Placebo + orange juice without vitamin D
Placebo + orange juice without vitamin D
干预措施: Placebo (Other)
Placebo + 1000 IU vitamin D3 in OJ
Vitamin D3 in orange juice
干预措施: Vitamin D3 in orange juice (Dietary Supplement)
Placebo + 1000 IU vitamin D2 in OJ
Vitamin D2 in orange juice
干预措施: Vitamin D2 in orange juice (Dietary Supplement)
1000 IU vitamin D2 + placebo OJ
1000 IU vitamin D2 + placebo OJ
干预措施: Vitamin D2 (Dietary Supplement)
1000 IU vitamin D3 + placebo OJ
1000 IU vitamin D3 + placebo OJ
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Measurement of 25(OH)D levels after ingestion of 1,000 IU of vitamin D2 or vitamin D3 in a capsule
时间窗: 11 weeks
次要结局
- Measurement 25(OH)D levels after taking vitamin D2 or vitamin D3 in orange juice(11 weeks)
研究者
Michael F. Holick
Michael . Holick PhD, MD
Boston University